Leading cardiac assist devices maker,
) achieved a major milestone by winning the Investigational
Device Exemption (IDE) clearance from the Food & Drug
Administration (FDA) for the use of its Impella RP (Right-side
Percutaneous) in a clinical trial called "Recover Right".
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The Recover Right clinical study will be headed by Mark Anderson,
M.D., chair of the Division of Cardiothoracic Surgery at Einstein
Healthcare Network and William O'Neill, M.D., medical director of
the Center for Structural Heart Disease at Henry Ford Hospital.
The study is expected to commence in early 2013 and is intended
to gather information on the safety and efficacy of the Impella
RP device. The device will be implanted in 30 patients and will
be monitored for the next 2 years.
Results from the study will be used by Abiomed to apply for a
Humanitarian Device Exemption (HDE) approval, for which the
company has already received a HUD (Humanitarian Use Device)
approval on July 13, 2012.
However, this product has not yet been approved by the FDA for
sale in the U.S. The company further plans to undergo a
biventricular "Bridge to Recovery" study in the future with the
Impella RP along with other Impella left-side products.
Impella RP has been designed as a support for right ventricular
dysfunction (right heart failure), which is characterized by the
inability of the right side of the heart to adequately pump
blood, resulting in accumulation of fluids in the body. Impella
RP provides the flow and pressure necessary to compensate for
right heart failure.
The device is inserted percutaneously (via the skin) into the
heart's right ventricle and delivers more than four liters of
blood from the lower right atrium to the pulmonary artery. The
Impella RP enables surgeons to treat right ventricular
dysfunction without cutting open the patient's chest.
Massachusetts-based Abiomed is engaged in developing,
manufacturing and marketing of medical products designed to
assist or replace the pumping function of the failing heart. The
company is enjoying strong demand for its Impella products.
Impella utilization continues to grow at a healthy pace, as is
evident from the increasing number of patients being treated with
However, we are aware of negative sentiments amongst investors
regarding the Impella 2.5 investigation process. In this
scenario, its competitors such as
) will likely take advantage of the situation and gain market
share. Our Neutral recommendation on the stock carries a
short-term Zacks #3 Rank (Hold) rating.